Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions (see here, here and here). On March 14, 2017, FDA made further progress on its Cures Act obligations by releasing in the Federal Register a proposed list of Class II devices that may be exempted from premarket notification (or 510(k)) requirements. The list is currently open for public comment until May 15, 2017. Under the Cures Act, the final list of exempted devices must be published by July 11, 2017.
From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible. However, given the political climate in the federal government and the lack of an appointed FDA commissioner, it is unclear whether FDA will hold its ground or be forced to retreat.
On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing of medical devices by entities other than the officially listed manufacturer. Although the deadline is drawing near (comments are due by May 3), only 36 comments have been submitted and almost none from manufacturers. This is surprising, given (1) the number of medical devices on the market that are critical to patient health, (2) the variety of independent servicing organizations (ISOs) and original equipment manufacturers (OEMs), which may or may not have appropriate quality standards or employ technicians with appropriate credentials, and (3) the enormous reporting and quality system responsibilities FDA imposes on manufacturers. All medical device manufacturers whose products could be serviced by ISOs once on the market should be weighing in on this issue to ensure FDA understands the risks associated with third-party servicing and the potential burdens new regulations could place on manufacturers. Continue Reading FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation